How To Achieve High Traceability in Pharmaceutical & Medical Devices In Marking & Coding
How to achieve simple, affordable enterprise traceability in the cloud
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Transcript of How to achieve simple, affordable enterprise traceability in the cloud
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HOW TO ACHIEVE SIMPLE,
AFFORDABLE ENTERPRISE
TRACEABILITY IN THE CLOUD
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The FDA and other government entities
are instituting traceability regulations for
pharmaceuticals and medical devices.
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Supply chain constituents will need to be
able to trace chains of custody from the
pharmacy back to the manufacturer.
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Emerging regulatory requirements in
global markets will include:
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Unit-level serialization.
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Point of sale verification.
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Central government reporting.
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Manufacturer-to-pharmacy traceability.
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But rigid point solutions to meet these
requirements become costly and
unmanageable over time.
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Why?
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Because new requirements always
emerge and change.
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So these supply chain constituents need
a DSCSA-ready, GS1-certified
serialization solution.
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One that centrally manages regulatory
requirements.
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One that reduces the cost and
complexity of compliance with
traceability laws.
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One that meets the needs of their
organization.
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Whether they have 1 million, 50 million,
or 100 million serialized items.
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Whether they do business with a
handful, dozens, or hundreds of
partners.
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They need to deploy a global traceability
and compliance solution via a private
cloud.
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They need to eliminate the overhead
required to expand their current
infrastructure.
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They need to leverage the economies of
scale inherent in cloud computing.
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They need to expect 21 CFR Part 11
compliance, the FDA requirement for
data integrity and digital signatures…
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…which assures better data security
and mature product offerings that
support good manufacturing practice.
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And they need to maintain the highest
levels of security, reliability and
scalability in a single-tenant
environment.
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With a global traceability and
compliance solution running in a private
cloud, they can:
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Reduce costs.
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Speed implementation and focus on
their core competencies.
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Improve reliability and performance.
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Take advantage of flexible processing,
storage, and deployment capabilities.
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Easily expand their trading community.
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Get immediate access to innovation, like
the latest features, patches, and
upgrades.
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And there’s no need for high-cost
consultants or extensive IT resources.
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Organizations can choose subscription-
based pricing to leverage the vendor’s
staff and infrastructure.
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The software is already up and running,
so they can deploy it in their enterprise
immediately.
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Customer design and data flows
leverage the vendor’s best practices and
management expertise.
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And if their needs change, they can
switch to an on-premise model for closer
integration with other enterprise apps.
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Or create a hybrid solution that perfectly
suits their business and technical
requirements.
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To all supply chain constituents, the
message is clear: The time is now!
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The FDA and other government entities
can introduce all the new requirements
they deem necessary.
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And you’ll always be ready.